Army sbir 08. 3 Proposal submission instructions
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| 6. Kleinheksel, K.A. & Summy, S.E. (2003). Enhancing Student Learning and Social Behavior Through Mnemonic Strategies. TEACHING Exceptional Children, 36(2), 30-35.
7. Levin, M.E. & Levin, J.R. (1990). Scientific mnemonomies: Methods for maximizing more than memory. American Educational Research Journal, 27, 301-321. 8. Mastropieri, M.A. and Scruggs, T.E. (1998). Enhancing School Success with Mnemonic Strategies. Intervention in School & Clinic, 33(4). KEYWORDS: memory, cognition, memorization strategies, mnemonics, emergency procedures training, pictorials A08-180 TITLE: Development of a Point-of-care Assay for the Detection of Rift Valley Fever (RVF) Virus, a Militarily Important Pathogen of the CENTCOM and AFRICOM Area of Operations TECHNOLOGY AREAS: Biomedical, Human Systems ACQUISITION PROGRAM: Principal Assistant for Acquisition, USAMRMC OBJECTIVE: Adapt state-of-the-art technology to develop a hand-held, field-deployable assay capable of detecting and identifying Rift Valley fever (RVF) virus in blood or serum samples from deployed military service members. DESCRIPTION: Requirement: To quickly and accurately determine whether a sick service member is infected with RVF virus. RVF has been documented as the #4 infectious disease threat to deployed service members using a quantitative algorithm for the prioritization of naturally-occurring disease threats to the U.S. military (ID-IDEAL) – the rapid identification of the pathogen causing illness is required in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities. In order to minimize medical evacuation and lost-duty time, identification of the pathogen should occur as far-forward as possible. Desired capability/concept of the final product: We envision a FDA-cleared, hand-held diagnostic assay capable of determining whether a given blood/serum sample is infected with RVF virus – assays capable of detecting RVF virus antigen and/or RVF virus-specific IgM antibody are desired. The assay must be rapid (<30 min), one- or two-step format, and stable (storage at 35 degrees C for 2 years). The assay should 80% as specific and 80% as sensitive compared to current gold-standard assays and should require a small (<50ul) sample volume. The assay must be service member-friendly (i.e., easy to operate), inexpensive, portable, use heat-stable reagents, and have no special storage requirements. A total of 10-25 individual assays should be packaged in a kit that contains all supplies necessary to run the assay. Appropriate controls (to include a positive antigen control or a positive antibody control, depending on whether the assay is an antigen- or antibody-detection assay) must be included in the kit. It is anticipated that the assay will be used in a low-complexity, austere environment, therefore the FDA moderate complexity requirement must be waived. PHASE I: Selected contractor determines the feasibility of the concept by developing a prototype diagnostic assay that has the potential to meet the broad needs discussed in this topic. By the conclusion of Phase I, the selected contractor provides a single lot of 100 prototype assays to the topic author. The degree to which the prototype assay meets the desired capability outlined above will be evaluated at a government laboratory – data from this independent evaluation will be used in the determination of the Phase II awardee. PHASE II: The goal in Phase II is the development of a prototype assay that provides 80% sensitivity and 80% specificity when compared to current gold standard assays (antigen and/or antibody detection ELISA or PCR assay) for RFV virus. Once sensitivity/specificity requirements have been met, the selected contractor conducts comprehensive evaluation of the assay performance under both laboratory and field conditions and gathers data needed to prepare a 510(k) application to the U.S. Food and Drug Administration. The selected contractor will also conduct stability testing of the device in Phase II. Stability testing will follow both real-time and accelerated (attempt to force the product to fail under a broad range of temperature and humidity conditions and extremes) testing in accordance with FDA requirements. The U.S. Army Medical Research and Material Command may provide support (access to medical laboratories and/or field sites, clinical samples, etc.) to facilitate the test and evaluation of the developed device. The selected contractor must coordinate closely with the COR to determine what support can be provided. It is envisioned that the successful completion of Phase II will require the use of clinical specimens obtained from humans, therefore the Phase II proposal must include a detailed description of the human subjects protection regulatory strategy that will be used to complete all necessary test and evaluation using clinical samples. This strategy should include types of clinical samples that will be used and proposed test sites, and should identify the Institutional Review Board (IRB) that will be used. The selected contractor will require a Federalwide Assurance of Compliance and a plan for Institutional Review Board reviews and approval before government funds can be provided for any effort that requires non-exempt human subjects research. The Phase II proposal must include a timeline for protocol development and regulatory approval. The feasibility (to include both scientific and ethical considerations) of the human subjects protection regulatory strategy outlined in the Phase II proposal will assist in the determination of the Phase II awardee. PHASE III: This assay will be suitable for use by far-forward military medical units (e.g. Battalion Aid Station) or medical personnel (e.g., Special Forces medics) to determine if sick military personnel are infected with RVF virus. This assay will also be available for non-military medical purposes, such as use by regional medical clinics or non-governmental organizations (NGOs) in areas of the world where RVF virus is endemic (e.g., Africa and the Middle East). We envision that the contractor that develops the RVF virus assay will be able to sell and/or market this assay to a variety of commercial medical organizations, and that this market will be adequate to sustain the continued production of this device. REFERENCES: 1. Flick R, Bouloy M. Rift Valley fever virus. Curr Mol Med. 2005 Dec;5(8):827-34. 2. Jansen van Vuren P, Potgieter AC, Paweska JT, van Dijk AA. Preparation and evaluation of a recombinant Rift Valley fever virus N protein for the detection of IgG and IgM antibodies in humans and animals by indirect ELISA. J Virol Methods. 2007 Mar;140(1-2):106-14. 3. Paweska JT, Jansen van Vuren P, Swanepoel R. Validation of an indirect ELISA based on a recombinant nucleocapsid protein of Rift Valley fever virus for the detection of IgG antibody in humans. J Virol Methods. 2007 Dec;146(1-2):119-24. 4. Paweska JT, Mortimer E, Leman PA, Swanepoel R. An inhibition enzyme-linked immunosorbent assay for the detection of antibody to Rift Valley fever virus in humans, domestic and wild ruminants. J Virol Methods. 2005 Jul;127(1):10-8. 5. Sobarzo A, Paweska JT, Herrmann S, Amir T, Marks RS, Lobel L. Optical fiber immunosensor for the detection of IgG antibody to Rift Valley fever virus in humans. J Virol Methods. 2007 Dec;146(1-2):327-34. 6. Zaki A, Coudrier D, Yousef AI, Fakeeh M, Bouloy M, Billecocq A. Production of monoclonal antibodies against Rift Valley fever virus Application for rapid diagnosis tests (virus detection and ELISA) in human sera. J Virol Methods. 2006 Jan;131(1):34-40. KEYWORDS: Rift Valley Fever virus, diagnosis, devices, field-deployable, far-forward, Point-of-Care A08-181 TITLE: Development of a Point-of-care Assay for the Detection of Crimean-Congo Haemorrhagic Fever (CCHF) Virus, a Militarily Important Pathogen of the CENTCOM, EUCOM and AFRICOM Area of Operations TECHNOLOGY AREAS: Biomedical, Human Systems ACQUISITION PROGRAM: Principal Assistant for Acquisition, USAMRMC OBJECTIVE: Adapt state-of-the-art technology to develop a hand-held, field-deployable assay capable of detecting and identifying CCHF virus in blood or serum samples from deployed military service members. DESCRIPTION: A. Requirement: To quickly and accurately determine whether a sick service member is infected with CCHF virus. CCHF virus has been documented as the #10 infectious disease threat to deployed service members using a quantitative algorithm for the prioritization of naturally-occurring disease threats to the U.S. military (ID-IDEAL) – the rapid identification of the pathogen causing illness is required in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities. In order to minimize medical evacuation and lost-duty time, identification of the pathogen should occur as far-forward as possible. B. Desired capability/concept of the final product: We envision a FDA-cleared, hand-held diagnostic assay capable of determining whether a given blood/serum sample is infected with CCHF virus – assays capable of detecting CCHF virus antigen and/or CCHF virus-specific IgM antibody are desired. The assay must be rapid (<30 min), one- or two-step format, and stable (storage at 35 degrees C for 2 years). The assay should 80% as specific and 80% as sensitive compared to current gold-standard assays and should require a small (<50ul) sample volume. The assay must be service member-friendly (i.e., easy to operate), inexpensive, portable, use heat-stable reagents, and have no special storage requirements. A total of 10-25 individual assays should be packaged in a kit that contains all supplies necessary to run the assay. Appropriate controls (to include a positive antigen control) must be included in the kit. It is anticipated that the assay will be used in a low-complexity, austere environment, therefore the FDA moderate complexity requirement must be waived. PHASE I: Selected contractor determines the feasibility of the concept by developing a prototype diagnostic assay that has the potential to meet the broad needs discussed in this topic. By the conclusion of Phase I, the selected contractor provides a single lot of 50 prototype assays to the topic author. The degree to which the prototype assay meets the desired capability outlined above will be evaluated at a government laboratory – data from this independent evaluation will be used in the determination of the Phase II awardee. PHASE II: The goal in Phase II is the development of a prototype assay that provides 80% sensitivity and 80% specificity when compared to current gold standard assays (antigen and/or antibody detection ELISA or PCR assay) for CCHF virus. Once sensitivity/specificity requirements have been met, the selected contractor conducts comprehensive evaluation of the assay performance under both laboratory and field conditions and gathers data needed to prepare a 510(k) application to the U.S. Food and Drug Administration. The selected contractor will also conduct stability testing of the device in Phase II. Stability testing will follow both real-time and accelerated (attempt to force the product to fail under a broad range of temperature and humidity conditions and extremes) testing in accordance with FDA requirements. The U.S. Army Medical Research and Material Command may provide support (access to medical laboratories and/or field sites, clinical samples, etc.) to facilitate the test and evaluation of the developed device. The selected contractor must coordinate closely with the COR to determine what support can be provided. It is envisioned that the successful completion of Phase II will require the use of clinical specimens obtained from humans, therefore the Phase II proposal must include a detailed description of the human subjects protection regulatory strategy that will be used to complete all necessary test and evaluation using clinical samples. This strategy should include types of clinical samples that will be used and proposed test sites, and should identify the Institutional Review Board (IRB) that will be used. The selected contractor will require a Federalwide Assurance of Compliance and a plan for Institutional Review Board reviews and approval before government funds can be provided for any effort that requires non-exempt human subjects research. The Phase II proposal must include a timeline for protocol development and regulatory approval. The feasibility (to include both scientific and ethical considerations) of the human subjects protection regulatory strategy outlined in the Phase II proposal will assist in the determination of the Phase II awardee. PHASE III: This assay will be suitable for use by far-forward military medical units (e.g. Battalion Aid Station) or medical personnel (e.g., Special Forces medics) to determine if sick military personnel are infected with CCHF virus. This assay will also be available for non-military medical purposes, such as use by regional medical clinics or non-governmental organizations (NGOs) in areas of the world where CCHF virus is endemic (e.g., Africa and the Middle East). We envision that the contractor that develops the CCHF virus assay will be able to sell and/or market this assay to a variety of commercial medical organizations, and that this market will be adequate to sustain the continued production of this device. REFERENCES: 1. Garrison AR, Alakbarova S, Kulesh DA, Shezmukhamedova D, Khodjaev S, Endy TP, Paragas J. Development of a TaqMan minor groove binding protein assay for the detection and quantification of Crimean-Congo hemorrhagic fever virus.Am J Trop Med Hyg. 2007 Sep;77(3):514-20. 2. Papa A, Drosten C, Bino S, Papadimitriou E, Panning M, Velo E, Kota M, Harxhi A, Antoniadis A. Viral load and Crimean-Congo hemorrhagic fever. Emerg Infect Dis. 2007 May;13(5):805-6. 3. Vorou R, Pierroutsakos IN, Maltezou HC. Crimean-Congo hemorrhagic fever. Curr Opin Infect Dis. 2007 Oct;20(5):495-500. 4. Ergönül O. Crimean-Congo haemorrhagic fever. Lancet Infect Dis. 2006 Apr;6(4):203-14. 5. Zhu Z, Dimitrov AS, Chakraborti S, Dimitrova D, Xiao X, Broder CC, Dimitrov DS. Development of human monoclonal antibodies against diseases caused by emerging and biodefense-related viruses. Expert Rev Anti Infect Ther. 2006 Feb;4(1):57-66. 6. Yapar M, Aydogan H, Pahsa A, Besirbellioglu BA, Bodur H, Basustaoglu AC, Guney C, Avci IY, Sener K, Setteh MH, Kubar A. Rapid and quantitative detection of Crimean-Congo hemorrhagic fever virus by one-step real-time reverse transcriptase-PCR. Jpn J Infect Dis. 2005 Dec;58(6):358-62. 7. Saijo M, Tang Q, Shimayi B, Han L, Zhang Y, Asiguma M, Tianshu D, Maeda A, Kurane I, Morikawa S. Antigen-capture enzyme-linked immunosorbent assay for the diagnosis of crimean-congo hemorrhagic fever using a novel monoclonal antibody. J Med Virol. 2005 Sep;77(1):83-8. 8. Saijo M, Tang Q, Shimayi B, Han L, Zhang Y, Asiguma M, Tianshu D, Maeda A, Kurane I, Morikawa S. Recombinant nucleoprotein-based serological diagnosis of Crimean-Congo hemorrhagic fever virus infections. J Med Virol. 2005 Feb;75(2):295-9. 9. Tang Q, Saijo M, Zhang Y, Asiguma M, Tianshu D, Han L, Shimayi B, Maeda A, Kurane I, Morikawa S. A patient with Crimean-Congo hemorrhagic fever serologically diagnosed by recombinant nucleoprotein-based antibody detection systems. Clin Diagn Lab Immunol. 2003 May;10(3):489-91. 10. Qing T, Saijo M, Lei H, Niikura M, Maeda A, Ikegami T, Xinjung W, Kurane I, Morikawa S. Detection of immunoglobulin G to Crimean-Congo hemorrhagic fever virus in sheep sera by recombinant nucleoprotein-based enzyme-linked immunosorbent and immunofluorescence assays. J Virol Methods. 2003 Mar;108(1):111-6. KEYWORDS: Crimean-Congo Haemorrhagic fever virus, diagnosis, devices, Point-of-Care A08-182 TITLE: Development of a Point-of-care Assay for the Detection of Sand Fly Fever Virus (SFFV), a Militarily Important Pathogen of the CENTCOM, EUCOM and AFRICOM Area of Operations TECHNOLOGY AREAS: Biomedical, Human Systems ACQUISITION PROGRAM: Principal Assistant for Acquisition, USAMRMC OBJECTIVE: Adapt state-of-the-art technology to develop a hand-held, field-deployable assay capable of detecting and identifying Sand fly fever virus (SFFV) in blood or serum samples from deployed military service members. DESCRIPTION: Requirement: To quickly and accurately determine whether a sick service member is infected with SFFV. SFFV has been documented as the #13 infectious disease threat to deployed service members using a quantitative algorithm for the prioritization of naturally-occurring disease threats to the U.S. military (ID-IDEAL) – the rapid identification of the pathogen causing illness is required in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities. In order to minimize medical evacuation and lost-duty time, identification of the pathogen should occur as far-forward as possible. Desired capability/concept of the final product: We envision a FDA-cleared, hand-held diagnostic assay capable of determining whether a given blood/serum sample is infected with SFFV – assays capable of detecting SFFV antigen and/or SFFV-specific IgM antibody are desired. The assay must be rapid (<30 min), one- or two-step format, and stable (storage at 35 degrees C for 2 years). The assay should 80% as specific and 80% as sensitive compared to current gold-standard assays and should require a small (<50ul) sample volume. The assay must be service member-friendly (i.e., easy to operate), inexpensive, portable, use heat-stable reagents, and have no special storage requirements. A total of 10-25 individual assays should be packaged in a kit that contains all supplies necessary to run the assay. Appropriate controls (to include a positive antigen control) must be included in the kit. It is anticipated that the assay will be used in a low-complexity, austere environment, therefore the FDA moderate complexity requirement must be waived. PHASE I: Selected contractor determines the feasibility of the concept by developing a prototype diagnostic assay that has the potential to meet the broad needs discussed in this topic. By the conclusion of Phase I, the selected contractor provides a single lot of 100 prototype assays to the Contracting Officer Representative (COR). The degree to which the prototype assay meets the desired capability outlined above will be evaluated at a government laboratory – data from this independent evaluation will be used in the determination of the Phase II awardee. PHASE II: The goal in Phase II is the development of a prototype assay that provides 80% sensitivity and 80% specificity when compared to current gold standard assays (antigen and/or antibody detection ELISA or PCR assay) for SFFV. Once sensitivity/specificity requirements have been met, the selected contractor conducts comprehensive evaluation of the assay performance under both laboratory and field conditions and gathers data needed to prepare a 510(k) application to the U.S. Food and Drug Administration. The selected contractor will also conduct stability testing of the device in Phase II. Stability testing will follow both real-time and accelerated (attempt to force the product to fail under a broad range of temperature and humidity conditions and extremes) testing in accordance with FDA requirements. The U.S. Army Medical Research and Material Command may provide support (access to medical laboratories and/or field sites, clinical samples, etc.) to facilitate the test and evaluation of the developed device. The selected contractor must coordinate closely with the COR to determine what support can be provided. It is envisioned that the successful completion of Phase II will require the use of clinical specimens obtained from humans, therefore the Phase II proposal must include a detailed description of the human subjects protection regulatory strategy that will be used to complete all necessary test and evaluation using clinical samples. This strategy should include types of clinical samples that will be used and proposed test sites, and should identify the Institutional Review Board (IRB) that will be used. The selected contractor will require a Federalwide Assurance of Compliance and a plan for Institutional Review Board reviews and approval before government funds can be provided for any effort that requires non-exempt human subjects research. The Phase II proposal must include a timeline for protocol development and regulatory approval. The feasibility (to include both scientific and ethical considerations) of the human subjects protection regulatory strategy outlined in the Phase II proposal will assist in the determination of the Phase II awardee. PHASE III: This assay will be suitable for use by far-forward military medical units (e.g. Battalion Aid Station) or medical personnel (e.g., Special Forces medics) to determine if sick military personnel are infected with SFFV. This assay will also be available for non-military medical purposes, such as use by regional medical clinics or non-governmental organizations (NGOs) in areas of the world where SFFV is endemic (e.g., the Mediterranean basin and the Middle East). We envision that the contractor that develops the SFFV assay will be able to sell and/or market this assay to a variety of commercial medical organizations, and that this market will be adequate to sustain the continued production of this device. REFERENCES: 1. Amaro F, Ciufolini MG, Venturi G, Fiorentini C, Alves MJ. [Phleboviruses laboratory diagnosis (Toscana virus)] Acta Med Port. 2007 Jul-Aug;20(4):341-6. Epub 2007 Nov 15. Portuguese. 2. Charrel RN, Gallian P, Navarro-Mari JM, Nicoletti L, Papa A, Sánchez-Seco MP, Dionisio D, Esperti F, Vivarelli A, Valassina M. Epidemiological, clinical and laboratory aspects of sandfly fever. Curr Opin Infect Dis. 2003 Oct;16(5):383-8. Review. 3. Tenorio A, de Lamballerie X. Emergence of Toscana virus in Europe. Emerg Infect Dis. 2005 Nov;11(11):1657-63. Review. 4. Touny I, Moussa MI, Shehata MG, Fryauff D, el Said S. Development of an enzyme linked-immunosorbent assay (ELISA) for the sand fly fever viruses detection. J Egypt Public Health Assoc. 1989;64(5-6):515-31. KEYWORDS: Sand fly fever virus, diagnosis, devices, point-of-care A08-183 TITLE: Cosmetic coating to protect unclothed skin from thermal (burn) injury TECHNOLOGY AREAS: Biomedical, Human Systems OBJECTIVE: To develop a topically applied cosmetic formulation that can protect unclothed skin surfaces, such as face and hands, from thermal injury in a fire. DESCRIPTION: Fire is a constant threat on the battlefield. While clothing provides a primary protection for much of the body, the hands and face are frequently left uncovered as a matter of comfort or for dexterity, access to equipment or situational awareness needs. Uncovered skin is extremely susceptible to injury in a fire, where the heat flux can range from 10 kW/m^2 to over 100 kW/m^2. At a heat flux of 40 kW/m^2, which is an intermediate value for fire situations that may be encountered on the battlefield, the exposure time required to cause second degree burns on exposed skin is about two seconds, according to the widely accepted Stoll burn injury criterion (1). At 80 kW/ m^2, which is typical of a so-called flash fire, the time to second degree burn is somewhat shorter, but still on the order of a second. The standard flash fire duration for purposes of evaluation of protective equipment is 3.0 seconds (2). If the heat flux to the skin were reduced (by means of the proposed protective coating) to 15 kW/ m^2, the Stoll model predicts a doubling of the time to second degree burn to four seconds. While this is still a very short time, this doubling of the time to burn could be a significant additional protection in a flash fire situation where the thermal threat is intense, but of relatively short duration. Reducing the heat flux to 10 kW/ m^2 increases the predicted time to burn to 10 seconds, a significant amount of additional time to escape or apply protective cover in a fast-moving fire scenario. Thermal energy is transferred to the skin from a fire through three primary mechanisms. These are radiation (the emission of intense infra-red (IR) radiation from the fire), convection (the transfer of heat through the movement of heated gas from the fire source to the skin) and conduction (the direct contact of hot matter such as burning building materials, etc., on the skin). Different strategies may be employed to counter each of these potential heat transfer mechanisms, and ideally all would be combined in a single product that would simultaneously protect against all routes of thermal energy transfer. Non-limiting examples of material functionality that could potentially be used in developing a cosmetic product to defeat the thermal exposure threats includes IR reflectivity to prevent radiation heating, phase change materials that could absorb heat before it reaches the skin, and intumescent materials that would expand when exposed to heat to form a protective insulation layer on the skin only when needed. While each of these materials technologies is known and has been demonstrated in some form for thermal protection applications (3-6) (but not as skin protectants), developing a viable cosmetic product for thermal protection of skin that incorporates all the required functionality will be a challenge on several levels. The product must be hypoallergenic, and it must also conform to the physical and enhanced protection performance capabilities listed in accordance to the Military specification, MIL-DTL-32000 (7). 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